Device recall
Z-1696-2025: Brand Name: Quantum Informatics - VISION / LIVE VUE Product Name: Monitor…
FDA device recall · Class II · Spectrum Medical Ltd.
Key facts
| Recall number (Z-number) | Z-1696-2025 |
|---|---|
| Recall event | 96616 |
| Product | Brand Name: Quantum Informatics - VISION / LIVE VUE Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VISION / LIVE VUE is a software-only device (SaMD) that is intended to provide near real-time patient safety and clinical best practice… |
| Product code | MWI |
| Recalling firm | Spectrum Medical Ltd. |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3006073153 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database